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Omnilux

FDA UDI

Class II (US FDA UDI)

by Lotus Global Group, Inc, The

Identity

Trade Name
OMNILUX FDA UDI
Generic Name
Musculoskeletal/physical therapy laser, professional FDA UDI
Device Name
OMNILUX MEDICAL BASE FDA UDI
Model / Reference
EM1258S FDA UDI
Description
OMNILUX MEDICAL BASE FDA UDI

Identifiers

Primary DI / UDI-DI
B434EM1258S0 FDA UDI
510(k) Number
K030426 FDA UDI
K030883 FDA UDI
K043317 FDA UDI
K043329 FDA UDI
K050216 FDA UDI
FDA Product Code
ILY FDA UDI
GEX FDA UDI
GMDN Term
Musculoskeletal/physical therapy laser, professional FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5500 FDA UDI
878.4810 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Musculoskeletal/physical therapy laser, professionalSkin photodynamic therapy/phototherapy lamp

Omnilux by Lotus Global Group, Inc, The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Skin photodynamic therapy/phototherapy lamp.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lotus Global Group, Inc, The

Sources (1)

  • FDA UDI 1545aeca-d853-400b-9969-6263a77039e9 34 fields · synced May 30, 2026